MD 30 - Dental implant motor system, SET - Nouvag AG

Duns Number:480610476

Device Description: Dental implant motor system, SET

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More Product Details

Catalog Number

-

Brand Name

MD 30

Version/Model Number

2004IDI

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K042434

Product Code Details

Product Code

DZI

Product Code Name

Drill, Bone, Powered

Device Record Status

Public Device Record Key

f890507c-603c-4735-8d67-57920015b6b6

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 13, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NOUVAG AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 72
2 A medical device with a moderate to high risk that requires special controls. 95